Please note, this job is not eligible for sponsorship.
This is an exciting role for a ClinicalTrials Assistant (CTA) to be part of a new network of NIHR Primary Care Clinical Research Delivery Centres (CRDC) (Primary Care) to deliver clinical trials based in Dorset. Within the NIHR Dorset CRDC (Primary Care) is an established collaboration consisting of 5 practices who have committed to work together delivering commercial research to our local population. We have a 2-year track record of successful trial delivery. The vision of the NIHR CRDC (Primary Care) is to enable practices across Dorset, who wish to be research active at whatever level, achieve this through the support of the NIHR CRDC (Primary Care). The Adam Practice (TAP) hosts the NIHR CRDC (Primary Care) and will support R&D function including study set up, delivery & finance management. All the practices in the NIHR CRDC (Primary Care) are partners and work as spokes delivering clinical trials for patient benefit.
Main duties of the job
Assist and support research nurses with completion of trial paperwork including transcribing/exporting data from medical records/GP Surgery IT systems to Case Report Forms (CRFs) (paper or electronic) as required by clinical trial protocols. Ensure clinic appointments/tests required for patients involved in trials are carried out according to the schedule in the protocol.
Provide general administrative support including filing, typing, fielding telephone calls, retrieving patient test results via hospital IT systems and arrange meeting dates, times and venues as directed by management.
Update the trials databases including EDGE with details of patients screened and recruited to trials/research. Training will be provided where necessary.
Assist research nurses in the day to day running of clinical trials, including completing lab work, full training will be given for this.
With assistance, make arrangements for pathological samples, radiological films and electronic data to be sent for central review.
Support the team in preparing documentation for monitoring visits including ensuring all study documentation is available to the monitors during their visit, arranging suitable meeting rooms and act as liaison when monitors are on-site.
To have an understanding that all research must be conducted according to ICH‑GCP, the EU Directive on Good Clinical Practice and the Research Governance Guidelines and assist the team in upholding these.
About us
The Adam Practice is a partnership of 16 GPs located across 5 surgeries in Poole, Dorset. This is an exciting opportunity to join our growing primary care team in a forward‑thinking, innovative, general practice, which has a current CQC rating of Outstanding in Care.
Our Research team give the best possible patient care and to benefit our patients. We have been an active research centre for the past 10 years and have worked on early phase studies up to later phase. We are now an accredited NIHR CRDC (Primary Care) facility.
As well as our work at the research hub we are continuing to recruit into complex commercial trials.
Additional benefits include access to NHS Pension Scheme and NHS discounts, 6.6 weeks annual leave (inclusive of bank/public holidays that fall in the holiday year). Entitlement is pro‑rata for part‑time employees.
Job responsibilities
The role of the CTA will be an integral role that will support the NIHR CRDC (Primary Care) in delivering gold standard clinical trials across 5 spoke sites as well as the hub site. Following research frameworks such as ICH‑GCP and UK Policy Framework for Health and Social Care Research (2017) you will be a support to the research nurses delivering these trials. Activities for this role include but are not limited to:
* Taking observations
* ECG readings
* Lab work
* Maintain ISFs
Person Specification
Qualities and Attributes
* Awareness of ICH‑GCP.
* Good attendance at work.
* A flexible approach to work.
* Effective time management.
* Strict attention to detail.
* Ability to work independently & as part of the team.
* Ability to organise, prioritise, co‑ordinate own self & work
* Takes accountability for one's actions.
* Shares information & good practice appropriately.
* Treats others with courtesy & respect at all times.
* Ability to prioritise tasks and meet deadlines
* Ability to use own judgement and commonsense
* Knowledge of research governance and regulations (ICH GCP & EU directives)
* Teaching experience
* Awareness of regulatory issues, legislation and guidance relating to clinical research
Qualifications
* Evidence of further education
* GCP training
Experience
* Experience within Secondary Care OR Primary Care.
* The ability to work autonomously.
* Basic PC knowledge
* Experience of using IT programmes.
* Systm One knowledge
Disclosure and Barring Service Check
This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.
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